A study to see whether we can increase the pain-free period in upper limb surgeries with regional anaesthesia block by adding dexmedetomidine to low-dose levobupivacaine

ISRCTN	ISRCTN55964940
DOI	https://doi.org/10.1186/ISRCTN55964940

Submission date: 27/10/2021
Registration date: 15/11/2021
Last edited: 29/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The aim of this study is to find out whether it is possible to reduce pain after upper limb surgery by adding dexmeditomedine to levobupivacaine in upper limb anaesthesia blocks.

Who can participate?
Patients aged 18-60 years who are undergoing upper limb surgery

What does the study involve?
Participants are randomly allocated to one of two groups. One group is given a nerve block with levobupivacaine and the other group is given levobupivacaine with dexmedetomidine. The onset time and duration of sensory and motor blockade and the time to first rescue pain relief are all recorded.

What are the possible benefits and risks of participating?
Participants may benefit from reduced pain after surgery.

Where is the study run from?
Bangalore Medical College and Research Institute (India)

When is the study starting and how long is it expected to run for?
October 2017 to September 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Vijayakumar HN
viji2751977@gmail.com

Contact information

Prof Vijayakumar H N
Scientific

Department of Anaesthesia
Victoria Hospital
Bangalore Medical College and Research Institute, FORT
Bangalore
560002
India

Phone	+91 (0)9886504680
Email	drhnv@yahoo.com

Study information

Study design	Double-blind randomized trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	A comparative study of the effect of 0.25% levobupivacaine in ultrasound-guided supraclavicular brachial plexus block
Study acronym	Dexlevo
Study objectives	Dexmeditomidine increases the onset and duration of motor and sensory block and duration of analgesia.
Ethics approval(s)	Approved 17/02/2018, Bangalore Medical College and Research Institute (Fort, Bangalore, Karnataka, 56002, India; +91 (0)80-26700810; director_bmcri@yahoo.co.in), ref: BMC/PGs/303/2017-18
Health condition(s) or problem(s) studied	Elective upper limb surgery
Intervention	60 ASA I and II patients aged between 18 to 60 years of either sex undergoing elective upper limb surgery lasting more than 30 minutes were included in the study. They were divided into two groups of 30 each in a randomised double-blind method. The patients underwent supraclavicular brachial plexus block under ultrasound guidance. Group L was given a nerve block with 20 ml of 0.25% levobupivacaine and 1 ml saline and group D received 20 ml of 0.25% levobupivacaine with 0.5 mcg/kg of dexmedetomidine (diluted to a volume of 1 ml). Onset time and duration of sensory and motor blockade and time to first rescue analgesia and hemodynamic variations were recorded.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Dexmeditomidine, levobupivacaine
Primary outcome measure	1. Sensory block assessed by atraumatic pinprick test using a three-point scale at 3, 6, 12, 15, 18, 21, 24, 27, 30 min 2. Motor block assessed using the Modified Bromage three-point scale at 5, 10, 15, 20, 25 and 30 min, and thereafter every 15 min for 2 h and then 30 min until the block effect has resolved 3. Sedation score assessed by the Ramsay sedation scale at 0, 5, 10, 15, 20, 25, 30 min 4. Pain assessed using a visual analogue scale (VAS) 0-10 at 0, 5, 10, 15, 20, 30 min, then hourly for 24 hours
Secondary outcome measures	1. Duration of analgesia measured using visual analogue scale hourly until the patient complains of pain over 24 h 2. Adverse events measured including hypotension, bradycardia, drop-in saturation, recorded by continuous monitoring for 24 h
Overall study start date	01/10/2017
Completion date	16/09/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	60
Total final enrolment	60
Key inclusion criteria	1. Undergoing elective upper limb surgery lasting more than 30 minutes 2. Aged 18-60 years 3. American Society of Anesthesiologists Classification (ASA) I and II
Key exclusion criteria	1. Hypertension 2. Uncontrolled diabetes 3. Arrhythmia 4. Renal failure 5. Liver failure 6. Bleeding tendencies 7. Pregnant 8. Neuropathy
Date of first enrolment	20/02/2018
Date of final enrolment	30/06/2019

Locations

Countries of recruitment

India

Study participating centre

Bangalore Medical College and Research Institute

Fort
Kalasipalya
Bangalore
560002
India

Sponsor information

Bangalore Medical College and Research Institute
Research organisation

Kalasipalya, Fort
Kalyan Nagar
Bangalore
560002
India

Phone	+91 (0)80 26700810
Email	director_bmcri@yahoo.co.in
Website	http://www.bmcri.org/
"ROR"	https://ror.org/05qmk4a18

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	30/12/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Vijayakumar HN (drhnv@yahoo.com).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		30/03/2022	29/11/2022	Yes	No

Editorial Notes

29/11/2022: Publication reference added.
28/10/2021: Trial's existence confirmed by Bangalore Medical College and Research Institute.